GMP Validation Specialist - Equipment & Systems

Serán BioScience; Bend (OR); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Paid time off

Retirement account

Health plans

Life insurance

Long-term disability

Employee Assistance Program

Pet insurance

Job summary

Serán BioScience in Bend, Oregon is seeking a Validation Associate to support qualification and validation activities for pharmaceutical manufacturing equipment, processes, and computerized systems used in tablet and capsule production for clinical FDA trials.

You will document lifecycle activities, work with cross-functional teams to troubleshoot equipment and validation issues, ensure GMP compliance, and help release equipment on schedule.

Qualifications

• Broad knowledge of Pharmaceutical GMP, FDA and international regulations.
• Strong documentation practices and change control understanding.
• Excellent verbal and written communication skills.
• Excellent organizational and time management skills.
• Proven problem-solving and analytical abilities.

Responsibilities

• Develop and manage system lifecycle documentation (URS, FDS, IQ/OQ/PQ, Traceability Matrix, Qualification Summary Reports).
• Assist with generation and maintenance of SOPs and supporting documents.
• Collaborate with cross-functional teams to troubleshoot equipment, process, and validation issues.
• Ensure GMP-compliant validation activities and timely release of equipment after qualification and cleaning.
• Perform investigations, CAPAs, change requests, and engineering projects.

Skills

GMP knowledge

Documentation

Communication

Time management

Problem solving

Teamwork

Office software

Education

Bachelor’s degree

Tools

Microsoft Office

Job description

Serán BioScience in Bend, Oregon is seeking a Validation Associate to support qualification and validation activities for pharmaceutical manufacturing equipment, processes, and computerized systems used in tablet and capsule production for clinical FDA trials.

You will document lifecycle activities, work with cross-functional teams to troubleshoot equipment and validation issues, ensure GMP compliance, and help release equipment on schedule.